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Agree with your numbers JRoon, with one caveat. We also have to take into consideration margins and net profit. With all the generics in the U.S. Amarin would have to take smaller margins and only a portion of sales here. But generally yes, if we could get AD as an indication that would change the dynamic in a big way.
Of course, even assuming stellar BRAVE-EPA results, approval imo won't be imminent but rather years away and something an acquiring BP would have. But I would factor that into BO negotiations.
No question. Not to make fun of JT, but the data was robust.
Does the ADA have a French equivalent and if so why didn't such organization petition HAS:
https://diabetes.org/newsroom/press-releases/2019/ada-issues-critical-updates-to-2019-standards-of-care
Yep. One would think (or at least hope) that even if they prioritize cost savings over patient health care that Vazkepa is a relatively cheap drug -- for the benefit it provides. That article or study posted by Kiwi included drugs that were far more expensive than V.
I am just wondering why HAS recommended excluding Vazkepa from diabetics as I thought R-I had great results within that segment.
Thanks Sleven for posting. The recommendation from HAS then goes (went) to the Health Ministry which then decided the reimbursement.
I am wondering if HAS’s refusal to include diabetics in the recommendation is a sticking point. I was not aware of that exclusion to V’s potential use in France.
Well, b) was no Oracle of Delphi revelation. As far as a) a classic example was KM thinking more of himself and bailing rather than working with the new team for the benefit of shareholders. Who would want that money grubbing group who were derelict in their fiduciary duties to shareholders.
Are you saying he was right about:
a) that we would be better off with the old guard
or
b) that the jump in stock price would drift back down?
If it was b) there were many of us that voiced the same idea that the pop in price on the news would be sold off as of course we all know Amarin's situation has not or will not change in a matter of weeks or months.
It says here that the last update was October 10, 2022, so later than your 2019 date.
It also says the study completion date (assuming it is not delayed further) is Sept. 29, 2023. But remember that they will then have to slice and dice the trial data and it may be 3, 4, or more months before we should expect even simply top line data.
https://clinicaltrials.gov/ct2/show/NCT02719327
I used to not have a very confident outlook concerning V wrt delaying, treating, or preventing AD. One of the main reasons was that AD is and is expected to explode in Japan. I was very confident in R-I results because of the low incidence of CVD in Japan (high consumption of EPA in the diet), and so thinking along the same lines, I was not confident that EPA would be very helpful in AD.
BUT I have changed my outlook. Here is an article outlining the rapid increase in AD coming the next years in Japan:
https://www.clinicaltrialsarena.com/comment/japan-will-fastest-growing-prevalent-cases-alzheimers/
BUT, the caveat is, that those larger numbers will be primarily because of the huge amount of aging Japanese, and aging is one of the big factors in AD. The other thing, that is not mention in the link above, but I have read about, is that the diet among the Japanese is changing. It could well be that although the geriatric population used to eat a diet high in EPA, that as they have aged and some of them in retirement homes, that they no longer eat as they used to. So all in all, I am hopeful that V can show some benefit to those susceptible to dementia and AD.
Sleven, JRoon, a good example of the new FDA standards and thinking was their approval of lecanemab earlier this year:
https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-disease-treatment
Lecanemab trial was considerably larger than BRAVE-EPA, was done on subjects with mild AD vs cognitively healthy subjects in BRAVE-EPA. IMHO, positive results in BRAVE-EPA would be greeted with calls for a larger study but would still boost stock price and would definitely spike interest with the BP community.
Thanks for reposting Sleven. I believe Cindy Carlsson and possibly Carol van Hulle are involved in the BRAVE-EPA trial.
Well said BW. After R-I, management decided that Nevada would be a great district for the generic lawsuit. Then they decided not to join a shareholders lawsuit that Marjac had in the bag, if not for the standing BS. Then proceeded with the lame brained idea of launching in the EU on their own. They dug a hole almost down to China.
Yep, me too. I woke my wife up that morning, something I had not done in a few decades.
Concerning BRAVE-EPA, I did notice a couple of things that I must have missed before.
Namely, some of the exclusion criteria.
First the LDL parameters. No more than 190 or LESS than 80 mg/dl.
And secondly, the exclusion of people with significant CVD or diabetes. Of course this is the primary target for currently treating with Vascepa.
According to the latest update on ClinicalTrials.gov, the estimated completion date is Sept. 29, 2023.
The trial is active and no longer recruiting. The problem is first whether the estimated completion date turns out to be the actual completion date (no delays, etc.) and secondly how long it will take for them to collate and dissect the data and then when they will release the results.
https://clinicaltrials.gov/ct2/show/NCT02719327?term=BRAVE&cond=dementia&draw=2&rank=1
Don't mean to butt in, but I think we looked these guys up before. When I go to www.scfpharma.com I get website hosting service.
Headquarters
235 Route Du Fleuve Ouest, Sainte Luce, Quebec, G0K 1P0, Canada
https://www.google.com/maps/place/235+Rte+du+Fleuve+O,+Sainte-Luce,+QC+G0K+1P0,+Canada/@48.530703,-68.4233561,366m/data=!3m1!1e3!4m16!1m9!3m8!1s0x4c95d66348624257:0x591647fd21fa7173!2s235+Rte+du+Fleuve+O,+Sainte-Luce,+QC+G0K+1P0,+Canada!3b1!8m2!3d48.530703!4d-68.4221169!10e5!16s%2Fg%2F11sh48pgb1!3m5!1s0x4c95d66348624257:0x591647fd21fa7173!8m2!3d48.530703!4d-68.4221169!16s%2Fg%2F11sh48pgb1?entry=ttu
This supposed study started 2 years ago and they can't find 30 people over 50 to just check their blood, because it says still recruiting.
At the bottom of your link we have this:
"
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No"
I don't think this is anything to worry about anymore than worrying about any OTC omega product.
I was thinking about a question asked by Yee and a post here (might have been from BBI but I could be wrong) about how moronic docs possibly are:
Michael Yee: "But let's be frank, that the cardiovascular readout was like five years ago, this has been approved in the U.S. -- it’s years ago, maybe not five. But with all due respect, our peers overseas in the pond are not unaware of the data. So, like why wouldn't some of the biggest centers, academic or otherwise, or the biggest KOLs would know about it? So is it, we went over to them is there's something like, oh, well, not aware of it, or it's not in the guidelines, or is the first time I ever saw an Amarin salesperson? Like what do you think is kind of the bottleneck there? "
Yee is specifically directing his question about why docs overseas are not aware of the data. But think of it redirected as a question about the U.S. Almost 5 years since R-I, WITH availability of generic versions, covered by almost all insurance companies (either V or GV or both). Look at the sorry state of scripts - can't even catch Lovaza for Pete's sake. Will docs here not prescribe something unless there is a billion dollar TV ad campaign?
I don't consider them practicing science, at least not the kind I learned 50-some years ago.
Appreciate your take and insights on the call. And agree with you about the docs.
But I am surprised at the elevation of KM to some kind of a mastermind. He flubbed the Germany launch and when you diss the slow rollout in the EU, that was all done by KM. The applications were all in before Denner took over.
I saw the mention of it but no real details or timeline. Also, my brain not working but he seemed to indicate a difference between branded generic and AG. Would someone bother doing both?
Merck suing US govt over Medicare price negotiation. Citing violations of 1st and 5th amendments.
https://www.reuters.com/business/healthcare-pharmaceuticals/merck-sues-us-government-halt-medicare-drug-price-negotiation-2023-06-06/
Not sure that your 1) and 2) mesh. First he has no plan, but in 2) he has a meticulous plan? Maybe you meant it is 1 or 2.
Thanks for posting Sleven.
I echo your sentiments Mr. main
Don’t understand people who think Denner should shut the doors since there is at this time no interest from any acquirer.
You still have to operate the business until the conditions develop that would foster a sale. Difference is, that prior management was not interested in a sale but Denner ultimately is.
Interesting. I should have mentioned I got mine from Fidelity.
Got my proxy this morning for the June 21 meeting. Still have to read the proxy statement before deciding how to vote.
Everyone else get it?
Amarin finds itself between a rock and a hard place. Prior managements have to take responsibility for that. Denner and his gang are our only hope of a way out of this morass. Hopefully the story ends up like you postulate, namely; that the share price eventually does magical things and we here will be rewarded. Some of us have been here a long, long, time.
https://www.amarincorp.eu/newsroom/marketing-auth-press-release
More than 2 years ago.
Yes, once the EMA gives approval it applies to all the EU countries. A centralized system.
After that, unfortunately, it is the reimbursement decisions that we are hung up with. And as opposed to the EMA approval which applies to all 28 countries, the reimbursements are the purview of each country.
Hopefully eventually all the biggies - Germany, France, Spain, Italy come through.
Thanks for posting Sleven. I see Sabouret on a number of twitter posts as a proponent for V
Not a whole lot of volume but sp definitely heading in the correct direction.
Good find Nuke. Thanks for posting.
Well, if he/she had stopped right after 1.41, I would have even Liked the post.
I thought the rest of the post violated TOS Code of Conduct #F and/or #G.
Not that I have been on that many boards, but I would say that over the last 10 years, as a whole, this Amarin board has been relatively fabulous - a great place to come and learn about our investment and a place to hear all ideas without very many spam posts to rifle through. I would prefer to have it stay that way.
Thanks Sleven, Kiwi.
Kiwi, or anyone, do we know how many will attend this HEART UK conference/symposium?
Is there a webcast for those docs that can't/don't want to attend in person? TIA
Thanks Sleven. Notice the placebo is mineral oil.
Buyouts to continue. Unfortunately nothing in this article points to Amarin but you never know:
https://www.investors.com/news/technology/biotech-stocks-are-in-blistering-ma-climate-ftc-could-change-that/?refcode=TechReport-06022023-2-FA-1:06:2023:2Q:NewsLetter:Email:TechReport-06022023:na:na:na:na:02:13:2:FA:1&j=2273842&sfmc_sub=103639478&l=222_HTML&u=31949780&mid=100016628&jb=9004
Thanks for the links Kiwi. Great stuff.
“The AMNOG process requires the pharmaceutical company to submit data from at least two large independent randomized double-blind trials that demonstrate the efficacy and safety of the new drug. “
So how could Amarin even submit an application if they needed 2 studies?
Hilarious that it also says they can require additional studies OR a lower price!!!
Drug not so good but OK if we pay less for it.
It definitely is...if and when it fully materializes.. But unfortunately the market is not buying it.....YET.
Thanks for posting. Shows the management is a rather dishonorable bunch.